Induction chemotherapy before surgery for early-stage lung cancer

A novel approach

K. M W Pisters, R. J. Ginsberg, D. J. Giroux, J. B. Putnam, M. G. Kris, D. H. Johnson, J. R. Roberts, J. Mault, J. J. Crowley, P. A. Bunn

Research output: Contribution to journalArticle

228 Citations (Scopus)

Abstract

Objective: This phase H trial assessed the feasibility, as measured by response rate, toxicity, resectability rate, and surgical morbidity and mortality rates, of perioperative paclitaxel and carboplatin chemotherapy in patients with early-stage non-small cell lung carcinoma. Methods: All patients required negative mediastinoscopy results and adequate medical parameters to undergo induction chemotherapy and an operation. Superior sulcus patients were excluded. Chemotherapy consisted of paclitaxel 225 mg/m2 over 3 hours and carboplatin (area under the curve = 6) every 21 days for 2 cycles preoperatively. Three postoperative cycles of chemotherapy were planned for patients undergoing complete resection. Results: Between June 1996 and July 1998, 94 patients were entered into the study. Sixty-five (69%) were men, and the median age was 64 years (range, 34-79 years). After induction chemotherapy, 53 of 94 (56%; 95% confidence interval, 46%-67%) had a major objective response, 88 (94%) underwent surgical exploration, and 81 (86%; 95% confidence interval, 78%-92%) underwent complete resection. Reasons for not undergoing an operation included disease progression (n = 3), clinically unresectable status (n = 1), death (n = 1), and patient lost to follow-up (n = 1). Two postoperative deaths occurred. Six (6%; 95% confidence interval, 0%-13%) pathologic complete responses were observed. Ninety (96%) patients received the planned preoperative chemotherapy versus 45% receiving postoperative chemotherapy. No unexpected chemotherapy or surgical morbidity occurred. The 1-year survival is currently estimated at 85%, and the median survival has not yet been reached. Conclusions: Induction chemotherapy with paclitaxel and carboplatin is feasible and produces a high response rate with acceptable morbidity and mortality rates in early-stage non-small cell lung carcinoma. A prospective randomized trial comparing 3 cycles of induction chemotherapy and surgery with surgery alone in early-stage non-small cell lung carcinoma is planned.

Original languageEnglish (US)
Pages (from-to)429-439
Number of pages11
JournalJournal of Thoracic and Cardiovascular Surgery
Volume119
Issue number3
StatePublished - 2000

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Induction Chemotherapy
Lung Neoplasms
Drug Therapy
Carboplatin
Paclitaxel
Non-Small Cell Lung Carcinoma
Confidence Intervals
Morbidity
Mediastinoscopy
Survival
Mortality
Lost to Follow-Up
Area Under Curve
Disease Progression

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Surgery

Cite this

Pisters, K. M. W., Ginsberg, R. J., Giroux, D. J., Putnam, J. B., Kris, M. G., Johnson, D. H., ... Bunn, P. A. (2000). Induction chemotherapy before surgery for early-stage lung cancer: A novel approach. Journal of Thoracic and Cardiovascular Surgery, 119(3), 429-439.

Induction chemotherapy before surgery for early-stage lung cancer : A novel approach. / Pisters, K. M W; Ginsberg, R. J.; Giroux, D. J.; Putnam, J. B.; Kris, M. G.; Johnson, D. H.; Roberts, J. R.; Mault, J.; Crowley, J. J.; Bunn, P. A.

In: Journal of Thoracic and Cardiovascular Surgery, Vol. 119, No. 3, 2000, p. 429-439.

Research output: Contribution to journalArticle

Pisters, KMW, Ginsberg, RJ, Giroux, DJ, Putnam, JB, Kris, MG, Johnson, DH, Roberts, JR, Mault, J, Crowley, JJ & Bunn, PA 2000, 'Induction chemotherapy before surgery for early-stage lung cancer: A novel approach', Journal of Thoracic and Cardiovascular Surgery, vol. 119, no. 3, pp. 429-439.
Pisters, K. M W ; Ginsberg, R. J. ; Giroux, D. J. ; Putnam, J. B. ; Kris, M. G. ; Johnson, D. H. ; Roberts, J. R. ; Mault, J. ; Crowley, J. J. ; Bunn, P. A. / Induction chemotherapy before surgery for early-stage lung cancer : A novel approach. In: Journal of Thoracic and Cardiovascular Surgery. 2000 ; Vol. 119, No. 3. pp. 429-439.
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abstract = "Objective: This phase H trial assessed the feasibility, as measured by response rate, toxicity, resectability rate, and surgical morbidity and mortality rates, of perioperative paclitaxel and carboplatin chemotherapy in patients with early-stage non-small cell lung carcinoma. Methods: All patients required negative mediastinoscopy results and adequate medical parameters to undergo induction chemotherapy and an operation. Superior sulcus patients were excluded. Chemotherapy consisted of paclitaxel 225 mg/m2 over 3 hours and carboplatin (area under the curve = 6) every 21 days for 2 cycles preoperatively. Three postoperative cycles of chemotherapy were planned for patients undergoing complete resection. Results: Between June 1996 and July 1998, 94 patients were entered into the study. Sixty-five (69{\%}) were men, and the median age was 64 years (range, 34-79 years). After induction chemotherapy, 53 of 94 (56{\%}; 95{\%} confidence interval, 46{\%}-67{\%}) had a major objective response, 88 (94{\%}) underwent surgical exploration, and 81 (86{\%}; 95{\%} confidence interval, 78{\%}-92{\%}) underwent complete resection. Reasons for not undergoing an operation included disease progression (n = 3), clinically unresectable status (n = 1), death (n = 1), and patient lost to follow-up (n = 1). Two postoperative deaths occurred. Six (6{\%}; 95{\%} confidence interval, 0{\%}-13{\%}) pathologic complete responses were observed. Ninety (96{\%}) patients received the planned preoperative chemotherapy versus 45{\%} receiving postoperative chemotherapy. No unexpected chemotherapy or surgical morbidity occurred. The 1-year survival is currently estimated at 85{\%}, and the median survival has not yet been reached. Conclusions: Induction chemotherapy with paclitaxel and carboplatin is feasible and produces a high response rate with acceptable morbidity and mortality rates in early-stage non-small cell lung carcinoma. A prospective randomized trial comparing 3 cycles of induction chemotherapy and surgery with surgery alone in early-stage non-small cell lung carcinoma is planned.",
author = "Pisters, {K. M W} and Ginsberg, {R. J.} and Giroux, {D. J.} and Putnam, {J. B.} and Kris, {M. G.} and Johnson, {D. H.} and Roberts, {J. R.} and J. Mault and Crowley, {J. J.} and Bunn, {P. A.}",
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T1 - Induction chemotherapy before surgery for early-stage lung cancer

T2 - A novel approach

AU - Pisters, K. M W

AU - Ginsberg, R. J.

AU - Giroux, D. J.

AU - Putnam, J. B.

AU - Kris, M. G.

AU - Johnson, D. H.

AU - Roberts, J. R.

AU - Mault, J.

AU - Crowley, J. J.

AU - Bunn, P. A.

PY - 2000

Y1 - 2000

N2 - Objective: This phase H trial assessed the feasibility, as measured by response rate, toxicity, resectability rate, and surgical morbidity and mortality rates, of perioperative paclitaxel and carboplatin chemotherapy in patients with early-stage non-small cell lung carcinoma. Methods: All patients required negative mediastinoscopy results and adequate medical parameters to undergo induction chemotherapy and an operation. Superior sulcus patients were excluded. Chemotherapy consisted of paclitaxel 225 mg/m2 over 3 hours and carboplatin (area under the curve = 6) every 21 days for 2 cycles preoperatively. Three postoperative cycles of chemotherapy were planned for patients undergoing complete resection. Results: Between June 1996 and July 1998, 94 patients were entered into the study. Sixty-five (69%) were men, and the median age was 64 years (range, 34-79 years). After induction chemotherapy, 53 of 94 (56%; 95% confidence interval, 46%-67%) had a major objective response, 88 (94%) underwent surgical exploration, and 81 (86%; 95% confidence interval, 78%-92%) underwent complete resection. Reasons for not undergoing an operation included disease progression (n = 3), clinically unresectable status (n = 1), death (n = 1), and patient lost to follow-up (n = 1). Two postoperative deaths occurred. Six (6%; 95% confidence interval, 0%-13%) pathologic complete responses were observed. Ninety (96%) patients received the planned preoperative chemotherapy versus 45% receiving postoperative chemotherapy. No unexpected chemotherapy or surgical morbidity occurred. The 1-year survival is currently estimated at 85%, and the median survival has not yet been reached. Conclusions: Induction chemotherapy with paclitaxel and carboplatin is feasible and produces a high response rate with acceptable morbidity and mortality rates in early-stage non-small cell lung carcinoma. A prospective randomized trial comparing 3 cycles of induction chemotherapy and surgery with surgery alone in early-stage non-small cell lung carcinoma is planned.

AB - Objective: This phase H trial assessed the feasibility, as measured by response rate, toxicity, resectability rate, and surgical morbidity and mortality rates, of perioperative paclitaxel and carboplatin chemotherapy in patients with early-stage non-small cell lung carcinoma. Methods: All patients required negative mediastinoscopy results and adequate medical parameters to undergo induction chemotherapy and an operation. Superior sulcus patients were excluded. Chemotherapy consisted of paclitaxel 225 mg/m2 over 3 hours and carboplatin (area under the curve = 6) every 21 days for 2 cycles preoperatively. Three postoperative cycles of chemotherapy were planned for patients undergoing complete resection. Results: Between June 1996 and July 1998, 94 patients were entered into the study. Sixty-five (69%) were men, and the median age was 64 years (range, 34-79 years). After induction chemotherapy, 53 of 94 (56%; 95% confidence interval, 46%-67%) had a major objective response, 88 (94%) underwent surgical exploration, and 81 (86%; 95% confidence interval, 78%-92%) underwent complete resection. Reasons for not undergoing an operation included disease progression (n = 3), clinically unresectable status (n = 1), death (n = 1), and patient lost to follow-up (n = 1). Two postoperative deaths occurred. Six (6%; 95% confidence interval, 0%-13%) pathologic complete responses were observed. Ninety (96%) patients received the planned preoperative chemotherapy versus 45% receiving postoperative chemotherapy. No unexpected chemotherapy or surgical morbidity occurred. The 1-year survival is currently estimated at 85%, and the median survival has not yet been reached. Conclusions: Induction chemotherapy with paclitaxel and carboplatin is feasible and produces a high response rate with acceptable morbidity and mortality rates in early-stage non-small cell lung carcinoma. A prospective randomized trial comparing 3 cycles of induction chemotherapy and surgery with surgery alone in early-stage non-small cell lung carcinoma is planned.

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JO - Journal of Thoracic and Cardiovascular Surgery

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